Overview
A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function
Status:
Completed
Completed
Trial end date:
2021-07-16
2021-07-16
Target enrollment:
0
0
Participant gender:
All
All
Summary
A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney functionPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers Squibb
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit www.BMSStudyConnect.com.
Inclusion Criteria:
- Participant must have renal impairment, as defined by eGFR at screening using the
Chronic Kidney Disease Epidemiology (CKD-EPI) equation
- No change in medications to control Chronic Kidney Disease (CKD) for at least 2 weeks
prior to dosing, and if possible, during confinement in the clinical research unit
(CRU), except those cleared by the investigator and Medical Monitor.
- Participants with normal renal function at screening, based upon the opinion of the
investigator's medical evaluation.
- Medically well-controlled disorders (eg, stable chronic asthma, allergy) are permitted
if the treatment for the disease does not interfere with the study.
- Women and men must use highly effective methods of contraception for the duration of
treatment
Exclusion Criteria:
- History of any significant drug allergy or drug-related Serious Adverse Events (SAE)
(such as anaphylaxis or hepatotoxicity)
- Positive results for drugs abuse in urine/saliva
- Participants undergoing any method of dialysis (eg, hemodialysis, peritoneal dialysis)
within the last 3 months or with anticipated need for dialysis during the study
- Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG, or clinical laboratory assessments beyond what
is consistent with the target population
- Known previous exposure to BMS-986259
Other inclusion/exclusion criteria apply